Complivit Aqua D3 drops for oral administration 15000 IU / ml, 10 ml

• Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia rickets).

• Rickets treatment.

• Complex therapy of osteoporosis of various origins.

Orally.

ComplivitЃ Aqua D3 is taken orally in a spoonful of liquid.

1 drop contains about 500 IU of vitamin D3.

Prevention of rickets:

- full-term newborns from 4 weeks of life - 1 drop (500 ME) per day;

- premature babies from 4 weeks of life - 2 drops (1000 ME) per day during the first year of life, then 1 drop (500 ME) per day.

The drug should be used during the first two years of a child's life during periods of low insolation (especially in winter).

Rickets treatment:

In the absence of visible deformities of the skeletal system (mild rickets) - 2-3 drops (1000-1500 ME) per day, continue treatment for 30 days.

In the presence of deformities of the skeletal system characteristic of moderate and severe rickets - 4-8 drops (2000-4000 ME) per day, continue treatment for 30-45 days, the dose of the drug and the duration of therapy depend on the severity of the changes and are determined by the doctor (see Special instructions').

Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia):

1 drop (500 IU) per day during the entire period of vitamin D deficiency. The minimum duration of the prophylaxis course is 1 month.

In the complex treatment of osteoporosis: 1-2 drops (500-1000 ME) per day for 3 months. Repeated courses of therapy are possible on the recommendation of a doctor, depending on the results of the assessment of markers of bone metabolism and calcium metabolism (see 'Special instructions').

For 1 ml:

Active ingredient: colecalciferol (vitamin D3) - 0.375 * mg (15000 ME);

Excipients: macrogol glyceryl ricinoleate - 75,000 mg; sucrose (white sugar) - 250,000 mg; sodium hydrogen phosphate dodecahydrate - 7,000 mg; citric acid (citric acid monohydrate) - 0.430 mg; anethole - 0.825 mg; benzyl alcohol - 15,000 mg; purified water up to 1 ml.

* 1 mg of Colecalciferol corresponds to 40,000 IU of vitamin D3 activity.

• Hypersensitivity to the components of the drug, especially to benzyl alcohol.

• Sucrase / isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption.

• Vitamin D hypervitaminosis.

• Increased level of calcium in the blood (hypercalcemia) increased excretion of calcium in the urine (hypercalciuria) urolithiasis (formation of calcium oxalate stones) incl. a history of renal osteodystrophy with hyperphosphatemia, pseudohypoparathyroidism.

• Sarcoidosis

• Acute and chronic liver and kidney disease, renal failure.

• Active form of pulmonary tuberculosis.

• Children's age up to 4 weeks of life.

Trade name of the drug

ComplivitЃ Aqua D3

International non-proprietary name

Colecalciferol

Dosage form

oral drops

Composition

For 1 ml:

Active ingredient: colecalciferol (vitamin D3) - 0.375 * mg (15000 ME);

Excipients: macrogol glyceryl ricinoleate - 75,000 mg; sucrose (white sugar) - 250,000 mg; sodium hydrogen phosphate dodecahydrate - 7,000 mg; citric acid (citric acid monohydrate) - 0.430 mg; anethole - 0.825 mg; benzyl alcohol - 15,000 mg; purified water up to 1 ml.

* 1 mg of Colecalciferol corresponds to 40,000 IU of vitamin D3 activity.

Description

Colorless, transparent or slightly opalescent liquid with a characteristic odor.

Pharmacotherapeutic group

Calcium-phosphorus metabolism regulator

ATX code

A11CC05

Pharmacodynamics:

Vitamin D3 is an active antirachitic factor. The most important function of vitamin D3 is to regulate calcium and phosphate metabolism, which promotes proper mineralization and skeletal growth.

Vitamin D3 is a natural form of vitamin D that is produced in human skin by exposure to sunlight. Compared to vitamin D2, it is characterized by 25% higher activity. Colecalciferol plays an essential role in the absorption of calcium and phosphates from the intestine in the transport of mineral salts and in the process of bone calcification also regulates the excretion of calcium and phosphates by the kidneys. The concentration of calcium ions in the blood causes the maintenance of muscle tone in the skeletal muscles, myocardial function promotes the conduction of nervous excitement, regulates the process of blood coagulation. Vitamin D is essential for the normal function of the parathyroid glands and is also involved in the functioning of the immune system by influencing the production of lymphokines.

Lack of vitamin D in food, a violation of its absorption, calcium deficiency and insufficient exposure to sunlight leads: in children during the period of intensive growth - to rickets in adults - to osteomalacia in pregnant women, tetany symptoms may occur in newborns - a violation of the processes of calcification of bone tissue. An increased need for vitamin D occurs in women during menopause due to the development of hormonal disorders leading to osteoporosis.

Pharmacokinetics:

Vitamin D3 aqueous solution is absorbed better than oil solution. In premature babies, there is insufficient formation and flow of bile into the intestines, which disrupts the absorption of vitamins in the form of oil solutions. After oral administration, colecalciferol is absorbed in the small intestine. It is metabolized in the liver and kidneys. The half-life of cholecalciferol from the blood is several days and can be extended in case of renal failure. The drug crosses the placental barrier and into the mother's milk. Vitamin D3 is cumulative. Excreted from the body by the kidneys in a small amount, most of it is excreted in the bile.

Indications:

• Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia rickets).

• Rickets treatment.

• Complex therapy of osteoporosis of various origins.

Contraindications:

• Hypersensitivity to the components of the drug, especially to benzyl alcohol.

• Sucrase / isomaltase deficiency; fructose intolerance; glucose-galactose malabsorption.

• Vitamin D hypervitaminosis.

• Increased level of calcium in the blood (hypercalcemia) increased excretion of calcium in the urine (hypercalciuria) urolithiasis (formation of calcium oxalate stones) incl. a history of renal osteodystrophy with hyperphosphatemia, pseudohypoparathyroidism.

• Sarcoidosis

• Acute and chronic liver and kidney disease, renal failure.

• Active form of pulmonary tuberculosis.

• Children's age up to 4 weeks of life.

Carefully:

In patients in a state of immobilization.

In patients taking thiazide diuretics as well as in patients with cardiovascular diseases taking cardiac glycosides (see the section 'Interaction with other medicinal products').

During pregnancy and breastfeeding (see section 'Use during pregnancy and during breastfeeding').

In infants with a predisposition to early overgrowth of fontanelles (when the small size of the anterior crown is established from birth).

When taking additional amounts of vitamin D and calcium (for example, as part of other drugs) in case of impaired excretion of calcium and phosphates in the urine during treatment with benzothiadiazine derivatives and in immobilized patients (risk of developing hypercalcemia and hypercalciuria) (see the section 'Special instructions').

In patients with the following concomitant diseases: atherosclerosis, heart failure, organic lesions of the heart, granulomatosis, hyperphosphatemia, phosphate nephrourolithiasis, diseases of the gastrointestinal tract, peptic ulcer of the stomach and duodenum, hypothyroidism.

If you have one or more of the listed diseases and conditions, you should consult your doctor before taking the drug.

Pregnancy and lactation:

During pregnancy, the drug should not be used in doses exceeding those recommended for the prevention of vitamin D deficiency (see section 'Dosage and Administration') due to the possibility of teratogenic effects in case of overdose.

Vitamin D3 should be prescribed with caution in women who are breastfeeding. the drug taken in high doses by the mother can cause overdose symptoms in the child.

If the drug is used during pregnancy and during breastfeeding, it is necessary to take into account the intake of vitamin D from other sources, the daily dose of vitamin D should not exceed 600 IU.

Method of administration and dosage:

Orally.

ComplivitЃ Aqua D3 is taken orally in a spoonful of liquid.

1 drop contains about 500 IU of vitamin D3.

Prevention of rickets:

- full-term newborns from 4 weeks of life - 1 drop (500 ME) per day;

- premature babies from 4 weeks of life - 2 drops (1000 ME) per day during the first year of life, then 1 drop (500 ME) per day.

The drug should be used during the first two years of a child's life during periods of low insolation (especially in winter).

Rickets treatment:

In the absence of visible deformities of the skeletal system (mild rickets) - 2-3 drops (1000-1500 ME) per day, continue treatment for 30 days.

In the presence of deformities of the skeletal system characteristic of moderate and severe rickets - 4-8 drops (2000-4000 ME) per day, continue treatment for 30-45 days, the dose of the drug and the duration of therapy depend on the severity of the changes and are determined by the doctor (see Special instructions').

Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia):

1 drop (500 IU) per day during the entire period of vitamin D deficiency. The minimum duration of the prophylaxis course is 1 month.

In the complex treatment of osteoporosis: 1-2 drops (500-1000 ME) per day for 3 months. Repeated courses of therapy are possible on the recommendation of a doctor, depending on the results of the assessment of markers of bone metabolism and calcium metabolism (see 'Special instructions').

Side effects:

The frequency of adverse reactions has not been determined.

Metabolic and nutritional disorders: hypercalcemia and hypercalciuria.

Nervous system disorders: headache.

Disturbances from the cardiovascular system: increased blood pressure arrhythmias.

Disturbances from the respiratory system of the chest and mediastinal organs: exacerbation of the tuberculous process in the lungs.

Disturbances from the gastrointestinal tract: decreased appetite, constipation, flatulence, nausea, abdominal pain or diarrhea.

Skin and subcutaneous tissue disorders: hypersensitivity reactions such as itching, skin rash and urticaria.

Musculoskeletal and connective tissue disorders: arthralgia myalgia.

Disorders of the kidneys and urinary tract: impaired renal function polyuria.

If you experience side effects, you should consult a doctor.

Overdose:

Symptoms of an acute overdose of vitamin D 3

early manifestations (caused by hypercalcemia) - constipation or diarrhea dryness of the oral mucosa headache thirst pollakiuria nocturia polyuria anorexia metallic taste in the mouth nausea vomiting general weakness and fatigue hypercalcemia hypercalciuria dehydration;

late manifestations - pain in the bones clouding of urine (appearance of hyaline casts of proteinuria leukocyturia in the urine) increased blood pressure pruritus photosensitivity of the eyes conjunctival hyperemia arrhythmia drowsiness myalgia nausea vomiting pancreatitis gastralgia weight loss rarely - psychosis (mental changes) and mood changes.

Symptoms of a chronic overdose of vitamin D 3 (when taken for several weeks or months for adults at doses of 20,000-60,000 IU / day for children - 2,000-4,000 IU / day): calcification of the soft tissues of the kidneys of the lungs of blood vessels; arterial hypertension, renal and chronic heart failure ( these effects most often occur when hyperphosphatemia is attached to hypercalcemia) impaired growth in children (long-term administration at a dose of 1800 IU / day).

Treatment . If the above symptoms appear, discontinue use of the drug and consult a doctor. A diet with a low calcium content (for several weeks) is shown, the consumption of large amounts of fluid, formed diuresis with the use of furosemide electrolytes, and the appointment of glucocorticosteroids calcitonin. With proper kidney function, calcium levels can be significantly reduced by infusion of isotonic sodium chloride solution (3-6 liters over 24 hours) with the addition of furosemide and in some cases also sodium edetate at a dose of 15 mg / kg / h while continuously monitoring calcium levels and electrocardiogram data. In case of oligoanuria, on the contrary, it is necessary to carry out hemodialysis (dialysate without calcium). The specific antidote is unknown.

To prevent overdose, in some cases, it is recommended to control the concentration of calcium in the blood.

Interaction:

Antiepileptic drugs (especially phenytoin and phenobarbital primidone) rifampicin cholestyramine reduce vitamin D3 reabsorption.

Concomitant use with hyazide diuretics increases the risk of hypercalcemia. In such cases, it is necessary to constantly monitor the concentration of calcium in the blood.

With hypervitaminosis D3, it is possible to increase the action of cardiac glycosides and an increase in the risk of arrhythmia due to the development of hypercalcemia (it is advisable to control the concentration of calcium in the blood of an electrocardiogram and adjust the dose of cardiac glycoside).

Concomitant glucocorticosteroid therapy may reduce the effectiveness of vitamin D3.

Long-term use of angacids containing aluminum and magnesium in combination with vitamin D3 can increase the concentration of aluminum and magnesium in the blood and, as a result, the toxic effect of aluminum on bone tissue and hypermagnesemia in patients with renal failure.

Cholestyramine colestipol and mineral oils reduce the absorption of fat-soluble vitamins in the gastrointestinal tract and require an increase in their dose.

Concomitant use of benzodiazepines increases the risk of hypercalcemia. Preparations containing high concentrations of calcium and phosphorus increase the risk of developing hyperphosphatemia.

When used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours; with oral forms of tetracyclines - at least 3 hours.

ќдновременное применение с другими аналогами витамина D повышает риск развити¤ гипервитаминоза витамина D.

 етоконазол может угнетать как биосинтез так и катаболизм 125(ќЌ)2-колекальциферола.

¬итамин D ¤вл¤етс¤ антагонистом препаратов примен¤емых при гиперкальциемии: кальцитонин этидронат памидронат пликамицин галли¤ нитрат.

»зониазид и рифампицин способны снижать эффект препарата из-за увеличени¤ скорости биотрансформации.

¬итамин D3 не взаимодействует с пищей.

ќсобые указани¤:

»збегать передозировки.

ѕри приеме препарата должно учитыватьс¤ количество витамина D и кальци¤ поступающих с пищей и в составе других лекарственных препаратов.

—лишком высокие дозы витамина D3 примен¤емые продолжительно или ударные дозы могут быть причиной хронического гипервитаминоза D3.

Ќе следует примен¤ть одновременно с витамином D3 высокие дозы кальци¤.

ѕрепарат следует примен¤ть с осторожностью у пациентов с нарушенной экскрецией кальци¤ и фосфатов с мочой при лечении производными бензотиадиазина и у иммобилизованных пациентов (риск развити¤ гиперкальциемии и гиперкальциурии). ” таких пациентов следует контролировать уровень кальци¤ в плазме крови и моче.

Ќе следует принимать витамин D3 при псевдогипопаратиреозе так как при этом заболевании потребность в витамине D может быть снижена что может привести к риску длительной передозировки.

  основным клиническим про¤влени¤м рахита легкой степени относ¤тс¤ нервна¤ возбудимость беспокойство вздрагивани¤ при резком звуке вспышке света нарушени¤ ритма сна поверхностный 'тревожный' сон потливость зуд кожи облысение затылка податливость краев большого родничка.

Ќаличие видимых деформаций костной ткани характерно дл¤ средней и т¤желой степени рахита которые как правило требуют госпитализации и проведени¤ комплексной терапии назначаемой врачом по результатам обследовани¤.

ѕовторное проведение курсов терапии остеопороза возможно по рекомендации врача в зависимости от результатов оценки маркеров костного обмена и обмена кальци¤. ?сли врач назначил более длительное лечение чем рекомендовано в инструкции то следует регул¤рно (через каждые три мес¤ца терапии) определ¤ть уровень кальци¤ в сыворотке крови и моче а также проводить оценку функции почек путем измерени¤ уровн¤ креатинина в сыворотке крови. ѕри необходимости доза может быть скорректирована врачом в соответствии с уровнем кальци¤ в сыворотке крови.

¬ случае гиперкальциемии или наличи¤ признаков нарушени¤ функции почек дозу препарата следует снизить или приостановить лечение. ?сли уровень кальци¤ в моче превышает 75 ммоль/24 ч (300 мг/24 ч) рекомендуетс¤ снизить дозу препарата или приостановить лечение.

¬ли¤ние на способность управл¤ть трансп. ср. и мех.:

?анные о возможном вли¤нии препарата на способность управл¤ть транспортными средствами и механизмами отсутствуют.

‘орма выпуска/дозировка:

 апли дл¤ приема внутрь 15000 ћ?/мл.

”паковка:

ѕо 10 мл во флаконы-капельницы из темного (¤нтарного) стекла укупоренные полиэтиленовыми пробками-капельницами и полиэтиленовыми крышками с контролем первого вскрыти¤.

ќдин флакон-капельницу вместе с инструкцией по применению помещают в пачку из картона.

”слови¤ хранени¤:

¬ защищЄнном от света месте при температуре не выше 25 ?—.

’ранить в недоступном дл¤ детей месте.

Shelf life:

2 years.

Do not use after the expiration date indicated on the package.

Vacation conditions

Without recipe

Manufacturer

Open Joint Stock Company 'Pharmstandard-Leksredstva' (OJSC 'Pharmstandard-Leksredstva'), 305022, Kursk, st. 2nd Aggregatnaya, 1a / 18, Russia

Marketing Authorization Holder / Organization Receiving Consumer Claims:

OTCPharm JSC